JOB DESCRIPTION
Piper Companies is currently looking for an experienced Validation Engineer in Summit, New Jersey (NJ) to work for an innovative and growing pharmaceutical manufacturer.
Responsibilities for the Validation Engineer include:
- Maintain all qualified and validated equipment/systems in compliance with policies, guidelines and procedures
- Support lab and manufacturing equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area
- Support the calibration, equipment qualification and validation activities
- ownership of all lifecycle deliverables in the Qualification of equipment and full CSV for single and multi-user Computerized Systems
- Regularly review, prioritize and promptly respond to customer equipment qualification and support requests.
- Develop validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls
- Develop the protocols, and associated reports while adhering to a change management process
Qualifications for the Validation Engineer include:
- A minimum of 5 years’ experience within the pharmaceutical manufacturing industry
- Strong knowledge of ISPE guidance and 21 CFR part 11 compliance
- Experience of MS Windows Client and server technologies
- Experience with FDA/GMP regulations
- B.S. in Engineering or related field required
Compensation for the Validation Engineer include:
- $95,000-$105,000 dependent upon experience
- Comprehensive benefits package
